Phase 1 Study Evaluating Safe Dose of KK2845 for Adults With Relapsed or Refractory Acute Myeloid Leukemia and Other Blood Cancers

What this Trial Is About

Researchers are evaluating KK2845 in adults with relapsed or refractory acute myeloid leukemia AML and other blood cancers in this first human study. The trial aims to determine the maximum tolerated dose MTD of KK2845 in Part 1 through dose escalation and to collect additional data on tolerated doses in Part 2. This study is sponsored by Kyowa Kirin Co., Ltd. and focuses on treatment for patients with limited standard options. Participants receive KK2845 at various dose levels to assess safety and tolerability. Part 1 involves gradually increasing doses to find the MTD, while Part 2 administers KK2845 at confirmed tolerable doses to gather further information. Each treatment cycle lasts 21 or 28 days, with dosing and assessments occurring throughout the intervention period. During the study, participants undergo regular evaluations including blood tests to monitor drug levels, immune response, and side effects. Researchers measure outcomes such as dose-limiting toxicity at the end of the first cycle, adverse events over about one year, treatment responses, remission duration, event-free survival, and overall survival up to one year post-treatment. The total participation period may last until November 2031, with ongoing safety and efficacy monitoring.

Phase I Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Other Hematologic Malignancies.